BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 886061 · Received July 27, 2007

    Report

    Report Number
    8031010-2007-00135
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Report Date
    June 29, 2007
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO PATIENT INJURY RESULTED IN THIS EVENT, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX-ANKER POST SEPARATED PRIOR TO PERFORMING A POLISHING PROCEDURE; THE SEPARATED PIECE WAS RETRIEVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIX ANKER ELR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR